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Coronavirus InfectionPhase 3EPICOSNCT04334928

Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel

A Phase 3 study testing Emtricitabine/tenofovir disoproxil and Hydroxychloroquine in people with Coronavirus Infection, run by Plan Nacional sobre el Sida (PNS) at 65 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Coronavirus Infection
What is being tested?
Emtricitabine/tenofovir disoproxil and Hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,002 participants
Where
65 sitesSpain
Study dates
15 Apr 2020to 11 Jul 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants that, after receiving appropriate information on the study design, objectives, possible risks and acknowledging they have the right to withdraw from the study consent at any time, sing the informed consent for participation in the study.
  • Male or female aged 18-70years.
  • Health care workers in public or private hospitals in areas of risk of SARS-CoV-2 transmission.
  • No previous diagnosis of SARS-CoV-2 (COVID-19) infection plus no symptoms compatible with SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study.
  • Understanding of the aim of the study and, therefore, acknowledging they have not been on any drug aiming at pre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of March 2020. This also includes PrEP for HIV.
  • Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause.
  • Women of reproductive age and their partners should commit to use and highly effective contraceptive method ( double barrier, hormonal contraception), during the study period and until 6 months after the last dose of treatment.

Who cannot join

  • Having symptoms suggestive of COVID-19 infection
  • HIV infection
  • Active hepatitis B infection.
  • Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.
  • Osteoporosis
  • Myasthenia gravis
Show all 15Show fewer
  • Pre-existent maculopathy.
  • Retinitis pigmentosa
  • Bradycardia < 50bpm
  • Weight < 40kg
  • Participant with any immunosuppressive condition or hematological disease.
  • Have taken any medications such as PrEP against SARS-CoV-2 from March 1, 2020 until trial entry (also includes PrEP for HIV).
  • Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
  • Breastfeeding
  • Known allergy to any of the medication used in this trial

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

Spain65 sites

  • Hospital de Araba

    Alava, Vitoria

  • Hospital General Universitario de Albacete

    Albacete

  • Hospital Principe de Asturias

    Alcalá de Henares, Madrid

  • Hospital Fundación de Alcorcón

    Alcorcón, Madrid

  • Hospital Nuestra Señora de Sonsoles

    Ávila

  • Centro Médico Teknon

    Barcelona

  • Hospital Clinic

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Dexeus

    Barcelona

  • Hospital Quirón Barcelona

    Barcelona

  • Hospital Universitario Sagrat Cor

    Barcelona

  • Hospital Universitario de Burgos

    Burgos

  • Hospital Infanta Margarita

    Cabra, Córdoba

  • Hospital Colllado Villalba

    Collado Villalba, Madrid

  • Hospital Virgen de la Luz

    Cuenca

  • Hospital General de Elche

    Elche, Alicante

  • Hospital Sant Joan de Deu de Esplugues

    Esplugues de Llobregat, Barcelona

  • Hospital Universitario de Ferrol

    Ferrol, A Coruña

  • Hospital de Getafe

    Getafe, Madrid, 28905

  • Hospital Clínico San Cecilio

    Granada

  • Hospital Insular de Las Palmas

    Las Palmas de Gran Canaria, Gran Canaria

  • Hospital Universitario de Canarias

    Las Palmas de Gran Canaria, Gran Canaria

  • Hospital Severo Ochoa

    Leganés, Madrid

  • Hospital Universitario de León

    León

  • Hospital Arnau de Vilanova

    Llíria, Valencia

  • Hospital San Pedro

    Logroño, La Rioja

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Infanta Leonor

    Madrid

  • Hospital La Princesa

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Virgen de la Victoria

    Málaga

  • Hospital Costa del Sol

    Marbella, Málaga

  • Hospital de Móstoles

    Móstoles, Madrid, 28935

  • Hospital Rey Juan Carlos

    Móstoles, Madrid

  • Hospital Reina Sofía

    Murcia

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • Complejo Asistencial de Palencia

    Palencia

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Hospital Quirón Pozuelo

    Pozuelo de Alarcón, Madrid

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital de Donostia

    San Sebastián, Guipuzcoa

  • Parc Sanitari Sant Joan de Déu de Sant Boi

    Sant Boi de Llobregat, Barcelona

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08970

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña

  • Hospital General de Segovia

    Segovia

  • Hospital Virgen del Rocio

    Seville

  • Hospital Virgen Macarena

    Seville

  • Hospital de Torrejón

    Torrejón de Ardoz, Madrid

  • Hospital Reina Sofía

    Tudela, Navarre, 31500

  • Hospital Infanta Elena

    Valdemoro, Madrid

  • Hospital Clinico Universitario

    Valencia

  • Hospital Dr. Peset

    Valencia

  • Hospital General de Valencia

    Valencia

  • Hospital La Fe

    Valencia

  • Hospital de Valladolid

    Valladolid

  • Hospital Rio Hortega

    Valladolid

  • Hospital Virgen del Castillo

    Yecla, Murcia

  • Hospital Lozano Blesa

    Zaragoza

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo

Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.

Read the detailed description

Healthcare workers are particularly at risk of SARS-CoV-2. In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specifically in healthcare workers is being sought. Administration of effective drugs to people at risk of developing an infectious disease is well accepted and is part of clinical practice. To date there are few on-going randomized clinical trial on Pre-exposure prophylaxis (PrEP) evaluating chloroquine and hydroxychloroquine efficacy for health care workers and other groups at high risk. Existing recent and scarce literature shows that RNA synthesis nucleos(t)ide analogue inhibitors, acting as viral RNA chain terminators, like TDF, abacavir or lamivudine, amongst others, could have an effect against SARS-CoV-2 infection. Worldwide, there is broad evidence of the use, safety and tolerability of hydroxychloroquine (200 mg) and TDF/FTC (245 mg/200 mg). This study aims to assess the efficacy of a daily single dose of TDF (245 mg)/FTC (200 mg), a daily single dose of HC (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain. Sample size calculations are based on the primary outcome; number of symptomatic confirmed infections by SARS-CoV-2. Briefly, 4.000 participants will be assigned to one of the 4 groups, through 1:1:1:1 randomization. Duration of prophylactic treatment will be 12 weeks from early April 2020 till early July 2020. Follow up of participants will continue up to 4 weeks after last dose of treatment. All participants will be assessed on a monthly basis. Interim analyses will be performed on monthly bases.

Being tested
Emtricitabine/tenofovir disoproxil, Hydroxychloroquine, Placebo: Emtricitabine/tenofovir disoproxil Placebo, Placebo: Hydroxychloroquine
Keywords
COVID-19, SARS-CoV-2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emtricitabine/tenofovir disoproxilDrug

    Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered.

  • HydroxychloroquineDrug

    Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered.

  • Placebo: Emtricitabine/tenofovir disoproxil PlaceboDrug

    Placebo: Tablets similar in appearance to Emtricitabine/tenofovir disoproxil

  • Placebo: HydroxychloroquineDrug

    Placebo: Tablets similar in appearance to Hydroxychloroquine

Study groups in NCT04334928
Study groupRoleWhat they receive
Emtricitabine/TenofovirExperimentalTenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg 1. Strength: 200 mg/245 mg tablets 2. Dose: one tablet once a day (both at dinner)
Receives: Drug: Emtricitabine/tenofovir disoproxil; Drug: Placebo: Hydroxychloroquine
HydroxychloroquineExperimentalHydroxychloroquine 200 mg + Placebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg 1. Strength: 200 mg tablets 2. Dose: one tablet once a day (both at dinner)
Receives: Drug: Hydroxychloroquine; Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo
Emtricitabine/Tenofovir+HydroxychloroquineExperimentalTenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Hydroxychloroquine 200 mg 1. Strength FTC/TDF:200 mg/245 mg tablets 2. Strength HC: 200 mg tablets 3. Dose: one tablet FTC/TDF plus one tablet HC once a day (at dinner)
Receives: Drug: Emtricitabine/tenofovir disoproxil; Drug: Hydroxychloroquine
PlaceboPlacebo comparatorPlacebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg 1. Placebo tablets with similar appearance to study drugs. 2. Dose: one tablet once a day (both at dinner)
Receives: Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo; Drug: Placebo: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19)

    Measured: 12 weeks

Secondary outcomes (2)

  1. Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19)

    assessed by:

    • No symptoms
    • Mild symptoms: general malaise, fever, cough, myalgia, asthenia.
    • Moderate symptoms: mild symptoms plus shortness of breath,
    • Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation

    Measured: 12 weeks

  2. Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start15 Apr 2020
  3. Primary completion25 Feb 2021
  4. Study completion11 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334928
Sponsor's protocol ID
PrEP COVID-19
Acronym
EPICOS
Status last verified
Sep 2021
First submitted
2 Apr 2020
Last updated
16 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Emtricitabine/tenofovir disoproxil and Hydroxychloroquine in people with Coronavirus Infection, run by Plan Nacional sobre el Sida (PNS) at 65 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

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